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ENDO USA, Inc. FDA Recalls
11 recalls on file across drugs, 5 of them Class I and 11 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, MalvernClass IIMar 13, 2026Crystallization; identified as Buprenorphine free base |
| Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured Class IIIOct 10, 2025Failed Impurities/Degradation Specifications: Out of specifi |
| Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, ManufacturedClass IIIOct 10, 2025Failed Impurities/Degradation Specifications: Out of specifi |
| Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured byClass IIIOct 10, 2025Failed Impurities/Degradation Specifications: Out of specifi |
| Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured Class IIIOct 10, 2025Failed Impurities/Degradation Specifications: Out of specifi |
| Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured byClass IIISep 5, 2025Failed Impurities/Degradation Specifications: Out of specifi |
| Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed Class IDec 20, 2024Labeling: Not Elsewhere Classified: misleading label similar |
| Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containiClass INov 18, 2024Labeling: Label Error on Declared Strength; Some cartons wer |
| Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 Class INov 18, 2024Labeling: Label Error on Declared Strength; Some cartons wer |
| Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containinClass INov 18, 2024Labeling: Label Error on Declared Strength; Some cartons wer |
| Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6Class INov 18, 2024Labeling: Label Error on Declared Strength; Some cartons wer |